Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000649819
Ethics application status
Approved
Date submitted
23/04/2021
Date registered
31/05/2021
Date last updated
2/05/2022
Date data sharing statement initially provided
31/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain structure, inner ear function and brain age in people who are long- term exercisers
Scientific title
Brain structure, inner ear function and brain age in people who are long- term exercisers
Secondary ID [1] 301428 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aging 321553 0
Dementia 321554 0
Balance Disorder 321555 0
Mild Cognitive Impairment 321556 0
Condition category
Condition code
Neurological 319301 319301 0 0
Studies of the normal brain and nervous system
Physical Medicine / Rehabilitation 319302 319302 0 0
Other physical medicine / rehabilitation
Neurological 319303 319303 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This cross-sectional observational study will recruit 15 healthy older adults between the ages of 60-65 years who have been regularly practicing Tai chi (TC) for at least 5 years from TC classes in the community. Participants undergo a battery of tests over 2 X 2.5 hour visits within a 2 week period including Cognitive tests, MRI, Vestibular testing and Balance testing and spatial navigation testing.
Intervention code [1] 320365 0
Not applicable
Comparator / control treatment
Fifteen participants who have never participated in TC or another long term exercise programme, will be recruited from the community and be matched for age, gender and years of education. They will undergo the same testing as the exercise group.
Control group
Active

Outcomes
Primary outcome [1] 327283 0
3T MAGNETOM SKYRA MRI- MRI assessing Brain Structure
Timepoint [1] 327283 0
Single timepoint study
Primary outcome [2] 327284 0
Video head impulse testing- vestibular function
Timepoint [2] 327284 0
Single timepoint study
Primary outcome [3] 327285 0
Cervical and ocular vestibular evoked myogenic potentials (VEMPS)- vestibular function
Timepoint [3] 327285 0
Single timepoint study
Secondary outcome [1] 394468 0
Pure-tone audiometry- auditory function
Timepoint [1] 394468 0
Single timepoint study
Secondary outcome [2] 394469 0
tympanometry- acoustic evaluation of the middle ear
Timepoint [2] 394469 0
Single timepoint study
Secondary outcome [3] 394470 0
Postural sway- Gait and Balance app
Timepoint [3] 394470 0
Single timepoint study
Secondary outcome [4] 394471 0
Clinical Test of Sensory Integration in Balance (CTSOB- M)
Timepoint [4] 394471 0
Single timepoint study
Secondary outcome [5] 394472 0
Vanderberg Mental Rotation Task
Timepoint [5] 394472 0
Single timepoint study
Secondary outcome [6] 394473 0
Design Memory, a sub-test of the Wechler Memory Scale- Fourth Edition (WMS-IV)
Timepoint [6] 394473 0
Single timepoint study
Secondary outcome [7] 394474 0
The Four Mountains Test- spatial memory
Timepoint [7] 394474 0
Single timepoint study
Secondary outcome [8] 394475 0
Triangle Completion Task- spatial navigation
Timepoint [8] 394475 0
Single timepoint study
Secondary outcome [9] 394476 0
Physical activity questionnaire adapted from Section B of the Healthy New Zealand questionnaire
Timepoint [9] 394476 0
Single timepoint study

Eligibility
Key inclusion criteria
Over all inclusion criteria: Adult between the ages of 60-65 inclusive with a t-MoCA of 19 or more.
In addition:
Exercise group: Have participated in a community Tai Chi class once a week or more most weeks for the past 5 or more years.
Control group: Have not participated in a regular group exercise programme over the past 5 years.
Minimum age
60 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria both groups:
MRI exclusions:
Cardiac pacemaker or defibrillator
Retained cardiac pacing wires
Surgical clips in the brain
Prosthetic heart valves (unless MR compatable)
Electronic inner ear implants
Metal fragments in your eyes
Electronic stimulators
Implanted pumps
Permanent eye liner
claustrophobia

Diagnosis of a neurological condition
Previous diagnosis of a vestibular condition (bar a single episode of BPPV)
Medically required to restrict head movements

Exclusion criteria specific to the control group
Have participated in an exercise group for more than 12 weeks in the previous year.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
For univariate analyses concerning specific differences between outcomes in the different groups, generalised linear mixed models (GLMMs) will be used, because they can accommodate highly correlated repeated measures data and also non-normally distributed variables via link functions. The relationships between different variables will be explored using multiple linear regression as well as machine learning methods such as random forest regression.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
Date of last participant enrolment
Anticipated
30/05/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 23619 0
New Zealand
State/province [1] 23619 0
Auckland

Funding & Sponsors
Funding source category [1] 305865 0
Charities/Societies/Foundations
Name [1] 305865 0
Eisdell Moore Centre
Country [1] 305865 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
90 Akoranga Drive
Northcote
Auckland 0627
Country
New Zealand
Secondary sponsor category [1] 306315 0
None
Name [1] 306315 0
Address [1] 306315 0
Country [1] 306315 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306125 0
Auckland University of Technology Ethics Committee
Ethics committee address [1] 306125 0
Ethics committee country [1] 306125 0
New Zealand
Date submitted for ethics approval [1] 306125 0
28/04/2021
Approval date [1] 306125 0
27/05/2021
Ethics approval number [1] 306125 0
21/123

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102798 0
Prof Denise Taylor
Address 102798 0
Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland 0627
New Zealand
Country 102798 0
New Zealand
Phone 102798 0
+64 09 921 9680
Fax 102798 0
Email 102798 0
[email protected]
Contact person for public queries
Name 102799 0
Denise Taylor
Address 102799 0
Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland 0627
New Zealand
Country 102799 0
New Zealand
Phone 102799 0
+64 09 921 9680
Fax 102799 0
Email 102799 0
[email protected]
Contact person for scientific queries
Name 102800 0
Denise Taylor
Address 102800 0
Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland 0627
New Zealand
Country 102800 0
New Zealand
Phone 102800 0
+64 09 921 9680
Fax 102800 0
Email 102800 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not made this an option on our ethics application.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.